The goal of this observational study is to compare the fluctuation patterns of biomarkers (Spirometry, FeNO, IOS) of responders and non-responders in asthma patients who will start treatment with a biologic. The main question it aims to answer is: Can fluctuation patterns of parameters for spirometry, FeNO and IOS before and after starting treatment with biologics in patients with severe asthma be used to predict a successful intervention.
Participants will measure Spirometry, FeNO and IOS twice a day at home for 2 or 3 months starting one month before starting treatment with a biological.

Start Date01 Dec 2023

Sponsor / Collaborator

Academic Medical Center University of Amsterdam

NCT04710134

/ CompletedPhase 4IIT

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy

Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

Start Date10 Feb 2021

Sponsor / Collaborator

McMaster University

[+1]

EUCTR2017-003958-16-NL

/ Unknown statusPhase 4IIT

Effect of Reslizumab on small airways in asthma. RESSAPEA

Start Date10 Aug 2018

Sponsor / Collaborator-

100 Clinical Results associated with Reslizumab

100 Translational Medicine associated with Reslizumab

100 Patents (Medical) associated with Reslizumab

391

Literatures (Medical) associated with Reslizumab

01 Jan 2025·The Journal of Allergy and Clinical Immunology: In Practice

Impact of smoking on biological treatment response in patients from the German Severe Asthma (GAN) Registry

Article

Author: Taube, Christian ; Buhl, Roland ; Bal, Christina ; Krall, Christoph ; Ehmann, Rainer ; Schmidt, Olaf ; Skowasch, Dirk ; Korn, Stephanie ; Schulz, Christian ; Brugger, Jonas ; Milger, Katrin ; Renner, Andreas ; Hamelmann, Eckard ; Biener, Leonie ; Jandl, Margret ; Stoshikj, Slagjana ; Idzko, Marco

BACKGROUNDClinical studies of biologics in severe asthma exclude smokers or ex-smokers (ExS) with over 10 pack-years (py). Thus, the effectiveness of this therapy in ex-smokers with severe asthma is not well understood.OBJECTIVESTo assess the impact of smoking on clinical efficiency of biologics in patients with severe asthma from the German Asthma Net (GAN), a comprehensive international registry.METHODSThis analysis included 1129 patients (55.8 % females, mean age 53.82 ± 14.67) from which 56% were never-smokers (NS), while 44% were ExS (<10 py: 22.9%, 10-20 py: 10.3%, >20 py: 10.6%). They received benralizumab (38.3%), dupilumab (28.9%), mepolizumab (18.3%), omalizumab (14%), or reslizumab (0.5%).RESULTSBiologic therapy significantly improved asthma control, measured by change in ACT, ACQ-5, and miniAQLQ, lung function, reduced exacerbations and daily oral prednisolone dose in all patients at week 52. Of note, no significant differences in asthma control between NS and ExS at week 52 (P=0.48, 0.09, and 0.15, respectively), were observed. Also, lung function improvement (FEV1, FVC, TLC, PEF, MEF50, P>0.05), reduction in AE (P=0.8) and OCS doses (P=0.15) were comparable in NS and ES. Markers of type 2 inflammation, such as fraction of exhaled nitric oxide (FeNO) and blood eosinophils, decreased in ex-smokers similarly to never-smokers (P=0.29 and P=0.48 respectively).CONCLUSIONIn summary, ex-smokers with severe asthma experienced similar improvements in asthma control, exacerbations, lung function and biomarkers as NS after one year of biologics, suggesting that severe asthmatics even with a substantial smoking history can benefit from biologic therapy.

01 Dec 2024·CHEST

The role of bronchial biopsy in the prediction of response to biological therapy in severe uncontrolled asthma: a prospective study

Article

Author: Bellvert, Cristina Gómez ; Pérez de Llano, Luis ; Toledo-Pons, Nuria ; Iglesias, Amanda ; Cosío, Borja G ; Escribano, Inés ; Shafiek, Hanaa ; Mosteiro, Mar ; Valera, Jose Luis

BACKGROUNDUp to two thirds of patients with severe uncontrolled asthma (SUA) who received biological therapy do not have a complete response.RESEARCH QUESTIONCan bronchial biopsy (BB) play a role in the identification of patients with SUA who has a better response to biological therapy?STUDY DESIGNAND METHODS: Prospective multicentre study. Consecutive SUA patients candidate to biological therapy underwent bronchoscopy and BB prior to biological therapy and clinical response was evaluated 6 months later. BB was evaluated according to a previously validated pathological score (PS) and was compared with a score of T2 inflammation (T2 score) that includes blood eosinophil count (BEC) and FeNO in predicting response to biological therapy. Response was graded as super-response, good response and partial/no response according to a composite score that includes exacerbations, oral corticosteroid (OCS) use, asthma control test (ACT) and improvement in FEV1.RESULTS92 patients were recruited and 78 completed the study, 63 of them received anti-IL5/5R (Mepolizumab, Reslizumab and Benralizumab) and 15 Dupilumab, being super-responders 36.5% and 26.6% respectively (p=0.126). The PS, but not the T2 score, was the only variable independently associated to response. Super-responders showed statistically significant higher PS. Response was better predicted by the PS compared to T2 score, in those receiving OCS and especially in those on anti-IL5/5R . Low tissue eosinophilia (<10 eosinophils/field) was associated to poor response to biological therapy.INTERPRETATIONBB is more precise in the prediction of response to biological therapy than the T2 score, especially in those requiring OCS or receiving anti-IL5/5R . Tissue eosinophilia is the main driver of this predictive capacity, but there are other items in the PS related to bronchial remodeling that might be contributing to the identification of response to biological therapy.

01 Nov 2024·The Journal of Allergy and Clinical Immunology: In Practice

Efficacy of Biologics in NSAID-ERD: United Airways From the Nose to the Bronchi

Review

Author: Reitsma, Sietze ; Buchheit, Kathleen M. ; Geveart, Phillippe ; Elzinga, Hester ; Fokkens, Wytske ; Buchheit, Kathleen M ; Elzinga, Hester B E ; Vandewalle, Elke

Nonsteroidal anti-inflammatory drug (NSAID)-exacerbated respiratory disease (NSAID-ERD), the clinical triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma, and respiratory reactions to cyclooxygenase 1 inhibitors, is often challenging to manage, with many patients failing first-line therapies for CRSwNP and asthma. There are now 6 biologic medications approved for asthma and/or severe CRSwNP: omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. With the availability of respiratory biologic treatment for both asthma and CRSwNP, clinicians now have a multitude of additional management options for patients with NSAID-ERD. Herein, we review the currently available clinical trial and real-world evidence for biologic efficacy and safety in patients with NSAID-ERD, discuss the mechanisms of biologic therapy specific to NSAID-ERD, and review evidence regarding the use of biologic therapy versus endoscopic sinus surgery for CRSwNP in patients with NSAID-ERD. We propose a management approach for choosing biologic therapy or endoscopic sinus surgery paired with aspirin therapy after desensitization for patients with NSAID-ERD.

News (Medical) associated with Reslizumab

12 Jul 2022

·medcitynews.com

Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma

The available treatments for eosinophilic asthma come with a wide range of side effect risks. Areteia Therapeutics is developing an oral therapy designed to match the blockbuster biologic drugs that treat this severe form asthma, but with a potentially better safety profile. On Tuesday, the new company unveiled its approach along with up to $350 million in financial commitments to support pivotal tests of its experimental medicine. Like other forms of asthma, eosinophilic asthma causes inflamed airways that are blocked by mucus, making it difficult to breathe. But eosinophilic asthma stems from a type of white blood cell called an eosinophil. In high levels, eosinophils cause inflammation in the airways. Areteia’s lead drug candidate is dexpramipexole, a first-in-class small molecule designed to block the maturation and release of eosinophils in the bone marrow, where these cells are produced. In a placebo-controlled Phase 2 test enrolling patients with moderate-to-severe eosinophilic asthma, company said that treatment with its drug led to significant, dose-dependent reduction in eosinophil levels in the blood at each of the three doses tested. Furthermore, the once-daily pill was well tolerated by patients and no serious adverse effects were reported. With the new capital, Areteia plans to advance to Phase 3 testing. Success there could bring redemption for a drug that previously fell short in amyotrophic lateral sclerosis (ALS). Dexpramipexole comes from the labs of Pittsburgh-based Knopp Biosciences. A decade ago, that privately held drug discovery company was developing dexpramipexole for ALS in a research partnership with Biogen. In 2013, Biogen reported that the drug failed its Phase 3 clinical trial. Under Knopp, the drug continued clinical development in eosinophilic asthma. The first line of eosinophilic asthma treatments are typically inhaled steroids. If the symptoms are severe, oral steroids offer another option. But long-term use of these drugs raises the risks of developing osteoporosis, weight gain and diabetes. Injectable biologic drugs offer yet another treatment option. These antibody drugs are designed to block interleukin 5, a signaling protein that plays a key role in the maturation of eosinophils. These drugs can also cause hypersensitivity reactions and raise the risk of infections, but that hasn’t stopped them from becoming big sellers. AstraZeneca’s Fasenra and GSK’s Nucala accounted for $1.2 billion and £1.14 billion (about $1.15 billion) respectively in 2021 revenue, according to company financial reports. Teva Pharmaceutical Industries markets Cinqair for eosinophilic asthma; that company’s annual report does not break out sales for individual products. Areteia was created by Knopp and Population Health Partners, a private equity firm that forms new companies around late-stage drug candidates with the potential to address prevalent diseases. If dexpramipexole can win regulatory approval as the first oral drug for eosinophilic asthma, the company said that it could become an alternative to biologic drugs with the potential of also finding use as an earlier line of therapy. The Series A round of funding announced Tuesday was led by Bain Capital Life Sciences. With the financing, dexpramipexole transfers from Knopp to Areteia. Other investors include Access Biotechnology, GV, Arch Venture Partners, Saturn Partners, Sanofi, Maverick Capital, and Population Health Partners. Photo credit: Jackie Niam, Getty Images

CollaborateSmall molecular drugAntibodyFirst in ClassFinancial Statement

08 Jun 2022

·www.prnewswire.com

Severe Asthma Market to Progress Upto USD 7 Billion by 2032 | DelveInsight

The increase in the Severe Asthma market size is a direct consequence of the expected launch of potential therapies an increase in the diagnosed prevalent population of Severe Asthma and increasing demand for personalized therapies. LAS VEGAS, June 8, 2022 /PRNewswire/ -- DelveInsight's Severe Asthma Market Insights report proffers a detailed comprehension of Severe Asthma market size by treatment, epidemiology, emerging therapies, market share of the individual therapies, current and forecasted Severe Asthma market size from 2019 to 2032 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan). Some of the salient features from the Severe Asthma Market Report : As per DelveInsight's analysis, the Severe Asthma market size in the 7MM was valued at almost USD 6 Billion in 2021 and is anticipated to grow at a CAGR of 5% for the study period (2019-2032). Key Severe Asthma companies such as GSK, AstraZeneca, Avillion, 4D Pharma, Avalo Therapeutics, Biosion, Roche, GenenTech, Boehringer Ingelheim Pharmaceuticals, Amgen, Pfizer, AB Science, Teva Pharmaceuticals, Sanofi, Regeneron Pharmaceuticals, Pieris Pharma, Novartis, Theravance Biopharma, and others are reported to bring a significant shift in the Severe Asthma market. The Severe Asthma emerging therapies that are expected to launch in the forecast period include GSK3511294, PT010, PT027, CSJ117, MRx-4DP0004, RG6173, CBP-201, PRS-060/AZD1402, BSI-045B, AVTX-002, and others. As per DelveInsight, the United States has the highest percentage of Severe Asthma patients pool among the 7MM. In addition to that, according to DelveInsight's analysts among the EU5 countries, the United Kingdom has the largest patient population of Severe Asthma, whereas Spain had the lowest patient population of Severe Asthma. Assessments as per DelveInsight's analysts indicate that Asthma diagnosed prevalence was more in adults than in pediatrics in the 7MM. The development of well-designed, randomized, controlled non-crossover trials with the potential benefits for Severe Asthma patients will drive the market growth in the forecast period. Also, approval and entry of new drugs will change the Severe Asthma market dynamics in the future. For further information on market impact by therapies, download the Severe Asthma market sample @ Severe Asthma Therapeutics Market Scenario Severe Asthma Overview Asthma is the most common chronic respiratory disease all over the globe. It affects the airways in the lungs, which become inflamed and narrowed due to various triggers, making it harder for air to flow out. It is a complex activity between airway inflammation and airway remodelling that results in airway hyper-responsiveness (AHR), which further leads to variable and excessive airway contraction. The characteristic Asthma symptoms include wheezing, shortness of breath, cough, a sensation of tightness in the chest, straining of neck and chest muscles, rapid breathing, and changes in heart rate. Asthma classification can be broadly done into intermittent or persistent. Here, Persistent asthma is further sub-divided based on severity into mild, moderate, and severe. Severe Asthma occurs due to various genetic, environmental, and psychological factors as well as respiratory infections. Severe Asthma symptoms appear often in the nighttime with a persistent airflow obstruction with a forced expiratory volume (FEV1) of less than 60% predicted before treatment. Based upon response to treatment, Severe Asthma is further classified into type-2 inflammation and non-type-2 inflammation. Type-2 inflammation includes allergic asthma and eosinophilic asthma (or e-asthma) while non-type-2 inflammation includes non-eosinophilic asthma. Severe Asthma Epidemiology Segmentation As per the assessment of DelveInsight, the total diagnosed prevalent (adult + pediatric) cases of Asthma in the 7MM was observed to be approximately 54 million cases in 2021. These cases are expected to increase by 2032. As per DelveInsight's estimates, among 7MM, the United States had the highest diagnosed cases of adult Asthma with almost 20 million cases in 2021. The Severe Asthma Market report proffers epidemiological analysis for the study period 2019-2032 in the 7MM segmented into Total Diagnosed Prevalent (adult + pediatric) Cases of Asthma Severity-specific Diagnosed Prevalent Cases of Asthma Type-specific Diagnosed Prevalent Cases of Severe Asthma Learn more about the Severe Asthma Population Trends for the 7 MM by downloading @ Severe Asthma Epidemiology Forecast Report Severe Asthma Market Outlook The fundamental goal of Asthma therapy is to minimize airway inflammation and also reduce the Asthma symptoms that come with it. To limit the likelihood of exacerbation, guidelines-based care focuses on illness severity and selecting the right medicinal therapy. Inhaled corticosteroids are the most common chronic asthma treatment, but quick-relief (reliever) or rescue medications are frequently used to reduce acute Asthma symptoms. Short-acting beta-agonists (SABAs) relieve airway bronchoconstriction quickly and are indicated as a symptom-relieving rescue drug. If asthma still isn't under control, long-acting beta 2 agonists (LABA), montelukast, or theophylline are added. If Asthma symptoms and flare-ups persist, oral corticosteroids are prescribed. There are currently six US FDA approved monoclonal antibodies for add-on biological Severe Asthma treatment. They include Cinqair (reslizumab) Teva Pharmaceutical, Dupixent (dupilumab) Sanofi, and Regeneron, Fasenra (benralizumab) AstraZeneca/Kyowa Kirin, Tezspire (tezepelumab) AstraZeneca and Amgen, Nucala (mepolizumab) GlaxoSmithKline, and Xolair (omalizumab) Novartis/Genentech. Several new severe asthma therapeutic options are currently being developed. The key assets include GSK3511294 (Depemokimab) by GlaxoSmithKline, PT010 (Breztri/Trixeo/BGF MDI (budesonide-glycopyrrolate-formoterol inhalation)) by AstraZeneca, and PT027 (BDA MDI/Budesonide/albuterol sulfate metered-dose inhaler) by AstraZeneca and Bond Avillion. They are in the late stage of development and are expected to launch in the forecasted period (2022-2032). Several other companies are also developing drugs for Severe Asthma treatment including Novartis (CSJ117), 4D pharma (MRx-4DP0004), Roche (RG6173), Pieris Pharma, and AstraZeneca (PRS-060/AZD1402), Biosion (BSI-045B), among others. Discover more about therapy set to grab substantial Severe Asthma market share @ Severe Asthma Market Landscape Severe Asthma Pipeline Therapies and Key Companies GSK3511294 (Depemokimab): GlaxoSmithKline PT010: AstraZeneca PT027: AstraZeneca and Avillion CSJ117: Novartis MRx-4DP0004: 4D pharma RG6173: Roche PRS-060/AZD1402: Pieris Pharma and AstraZeneca BSI-045B: Biosion AVTX-002: Avalo Therapeutics To know about more pipeline therapies covered in the report, visit @ Severe Asthma Pipeline Analysis, Clinical Trials, and Emerging Therapies Severe Asthma Market Dynamics Severe Asthma market growth in the coming years is dependent on several factors such as an increase in the diagnosed prevalent population of Severe Asthma and increasing demand for personalized therapies. Also, the development of well-designed, randomized, controlled non-crossover trials with the potential benefits for patients will drive the Severe Asthma market growth in the forecast period. In addition to that, approvals and entry of new drugs will change the Severe Asthma market dynamics in the future. Several pharmaceutical giants are investigating drugs for Severe Asthma treatment with an improved diagnostic approach leading to a rise in the Severe Asthma market in the coming years. On the other hand, a lack of effective specific treatments in non-eosinophilic asthma (NEA) can represent an orphan asthma endotype serving as a drawback in the Severe Asthma market growth. Other factors such as a high cost of treatment, limitations in diagnosis, incorrect inhaler techniques, and poor adherence to treatment can all be considered as potential barriers to the rise of the Severe Asthma market. Know which therapy is expected to score the touchdown first @ Severe Asthma Market Landscape and Forecast Scope of the Severe Asthma Market Report Study Period: 2019-2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Severe Asthma Companies: GSK, AstraZeneca, Avillion, 4D Pharma, Avalo Therapeutics, Biosion, Roche, Amgen, Avalo Therapeutics, Teva Pharmaceuticals, Sanofi, Regeneron Pharmaceuticals, Pieris Pharma, Novartis, and many others. Key Severe Asthma Pipeline Therapies: GSK3511294, PT010, PT027, CSJ117, MRx-4DP0004, RG6173, PRS-060/AZD1402, BSI-045B, AVTX-002, and others Severe Asthma Therapeutic Assessment: Severe Asthma current marketed and emerging therapies Severe Asthma Market Dynamics: Severe Asthma market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Severe Asthma Market Access and Reimbursement Request for a Webex demo of the report @ Severe Asthma Therapeutics Market Table of Contents Get in touch with our Business executive @ Severe Asthma Market Landscape Analysis Related Reports Asthma Market DelveInsight's "Asthma Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Asthma, historical and forecasted epidemiology, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market. Allergic Asthma due to Dermatophagoides Farinae Market DelveInsight's "Allergic Asthma due to Dermatophagoides Farinae- Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Allergic Asthma due to Dermatophagoides Farinae, historical and forecasted epidemiology, current Allergic Asthma due to Dermatophagoides Farinae treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market. Eosinophilic Asthma Market DelveInsight's "Eosinophilic Asthma Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Eosinophilic Asthma, historical and forecasted epidemiology, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market. Asthma Epidemiology DelveInsight's 'Asthma - Epidemiology Forecast to 2032' report delivers an in-depth understanding of the disease, historical and forecasted Asthma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Pulse Oximeters Market DelveInsight's 'Pulse Oximeters Market Insights, Competitive Landscape and Market Forecast - 2027' report deliver an in-depth understanding of Pulse Oximeters, historical and forecasted Pulse Oximeters market trends, market drivers, market barriers, and key companies involved like Medtronic, Nonin Medical Inc, Lepu Medical Technology, TytoCare Ltd, VYAIRE, OMRON Corporation. Meditech Equipment Co ., Ltd, and several others. Cough Assist Devices Market "DelveInsight's 'Cough Assist Devices Market Insight, Competitive Landscape and Market Forecast, 2027' report delivers an in-depth understanding of Cough Assist Devices and the historical and forecasted Cough Assist Devices market trends, market drivers & barriers, unmet needs and key companies involved such as Koninklijke Philips N.V, Percussionaire Corp., Emerson, Hill Rom, Dima Italia SRL, and many more. Cough in Idiopathic Pulmonary Fibrosis Market DelveInsight's 'Cough in Idiopathic Pulmonary Fibrosis (IPF)-Market Insights, Epidemiology and Market Forecast– 2032' report delivers an in-depth understanding of the cough in IPF, historical and forecasted epidemiology as well as the Cough in IPF market trends, market drivers & barriers, unmet needs and key companies involved such as Algernon Pharmaceuticals, Trevi Therapeutics, Nerre Therapeutics, and others. Chronic Obstructive Pulmonary Disease Market DelveInsight's 'Chronic Obstructive Pulmonary Disease (COPD)-Market Insights, Epidemiology, and Market Forecast–2032' report deliver an in-depth understanding of the Chronic Obstructive Pulmonary Disease (COPD), historical and forecasted epidemiology as well as the Chronic Obstructive Pulmonary Disease (COPD) market trends, market drivers & barriers, unmet needs and key companies involved such as AstraZeneca, Amgen, Circassia Pharmaceuticals Inc, Biomarck Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Chiesi Farmaceutici, Genentech, GlaxoSmithKline, Theravance, Innoviva, Inmunotek, Mereo BioPharma, Novartis Pharmaceuticals, and several others. Asthma Diagnostic Devices Market "DelveInsight's 'Asthma Diagnostic Devices Market Insight, Competitive Landscape and Market Forecast, 2027' report delivers an in-depth understanding of Asthma Diagnostic Devices and the historical and forecasted Asthma Diagnostic Devices market trends, drivers, barriers, and key companies involved such as Medline Industries, Becton, Dickinson and Company, Siemens Process Instrumentation, Smiths Medical, Vyaire Medical, Nihon Kohden Corporation, Vitalograph, Circassia Limited, Intermedical (UK) Limited, and several others. Chronic Obstructive Pulmonary Disease Treatment Devices Market "DelveInsight's 'Chronic Obstructive Pulmonary Disease Treatment Devices Market Insight, Competitive Landscape and Market Forecast, 2027' report delivers an in-depth understanding of Chronic Obstructive Pulmonary Disease Treatment Devices and the historical and forecasted Chronic Obstructive Pulmonary Disease Treatment Devices market trends, drivers, barriers and key companies involved such as GlaxoSmithKline plc, Novartis AG, Merck & Co., Koninklijke Philips N.V, AstraZeneca, 3M, GF HEALTH PRODUCTS, Sunovion Pharmaceuticals Inc, Smiths Medical, Baxter, and others. Interested to know more about the breakthrough happenings? Take a look at the posts below Asthma: Rising Prevalence And The Key Challenges In The Management Chronic Refractory Cough Market and the Monopoly of the Over-The-Counter Drugs Alarming Growth of Chronic Respiratory Diseases (CRDs) and Their Prolonged Impact on the Quality of Life About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect With Us at LinkedIn | Facebook | Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

Antibody

07 Sep 2021

·www.biospace.com

New Phase III Data Reaffirms Tezepelumab’s Potential for Severe Asthma

Al Seib / Los Angeles Times via Getty Images Tezepelumab is showing potential as a new biological therapy for severe refractory asthma. Though there is preliminary data from randomized clinical trials to suggest that the experimental drug, being developed by Amgen and AstraZeneca, is safe and effective for patients with severe, uncontrolled asthma, new data from the pivotal Navigator Phase III trial reaffirms it. The data analysis, announced Sunday, demonstrated that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with comorbid nasal polyps. The novel drug, being co-developed as part of a collaboration between the pharma giants, offers hope to the one in five people with severe asthma who also have nasal polyps. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) and granted Priority Review for tezepelumab in early July. The drug had previously received Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in 2018. At the time, Mene Pangalos, AstraZeneca’s EVP, BioPharmaceuticals R&D said it has the potential to transform treatment for a broad population of severe asthma patients. The pair are developing tezepelumab in hopes of identifying a new class of human monoclonal antibodies that can target the primary site of inflammation, the airways, where viruses and allergens are inhaled. The novel biologic reduced exacerbations by 56%, according to a study published in The New England Journal of Medicine, with the Navigator data reinforcing that tezepelumab is the only biologic to reduce exacerbations consistently and significantly in a wide sampling of this group. The pre-specified exploratory analysis evaluated the effect of tezepelumab in patients with or without reported nasal polyps in the past two years. The review showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate with patients having nasal polyps, and 52% in patients not having nasal polyps. Tezepelumab improved lung function and achieved a clinically relevant improvement in nasal polyp symptoms at week 52 in both groups of patients. The drug blocks thymic stromal lymphopoietin (TSLP), which is at the top of numerous inflammatory cascades and triggers an overreactive immune response in allergic, eosinophilic, and other types of asthmatic inflammation. TSLP levels are correlated with disease severity, airway obstruction, and resistance to glucocorticoids. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients. Approximately 2.5 million people suffer from severe asthma worldwide, including about one million Americans. Currently available biologics and oral corticosteroids do not effectively control severe asthma. Additionally, a significant proportion of asthmatics have comorbid nasal polyps that may lead to breathing problems or negatively affect the quality of their lives, such as a reduction in sense of smell, sleep disturbances and a reduction in immunity. It is here that Amgen and AstraZeneca appear to have scored, with their Navigator and Path Finder clinical trial program, establishing the case for what they believe will be a blockbuster asthma drug. Analysts have estimated that peak sales could amount to $2 billion, and by 2026, GlobalData anticipates that the drug will bring in $1.8 billion from worldwide sales. Welcoming the results, Dr. David Reese, EVP of research and development at Amgen said the results further strengthened the firm's confidence in tezepelumab’s potential to address a significant unmet need. Authorized medicines to treat severe, uncontrolled asthma include GlaxoSmithKline's Nucala, Sanofi and Regeneron Pharmaceuticals' Dupixent and AstraZeneca's Fasenra, but these are only approved for patients with high levels of eosinophils. Tezepelumab, an injectable subcutaneous monoclonal antibody, is one of the more advanced monoclonal antibodies that blocks TSLP. Recent clinical and immunological phenotypic classifications of asthma have encouraged the development of new therapeutic strategies, such as the discovery of monoclonal antibodies targeted to IgE (anti-IgE/omalizumab), or anti-interleukin-5 (IL-5), specific for the Type 2 (T2)-high eosinophilic phenotype. Anti-IgE therapy with omalizumab was the first therapeutic option for the treatment of severe allergic asthma. Anti-IL-5 biologics such as mepolizumab, reslizumab and anti-IL-5 receptor alpha subunit such as benralizumab have recently been approved as add-on treatments in patients with severe eosinophilic refractory asthma. To date, other drugs are being developed aimed at treating the T2-high phenotype. Featured Jobs on BioSpace

CollaborateAntibodyBreakthrough TherapyPriority ReviewLicense out/in

100 Deals associated with Reslizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D08985	Reslizumab	R03DX08	DB06602

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pulmonary Eosinophilia	IS	Teva Pharmaceuticals Europe BV	15 Aug 2016
Pulmonary Eosinophilia	EU	Teva Pharmaceuticals Europe BV	15 Aug 2016
Pulmonary Eosinophilia	LI	Teva Pharmaceuticals Europe BV	15 Aug 2016
Pulmonary Eosinophilia	NO	Teva Pharmaceuticals Europe BV	15 Aug 2016
Eosinophilic Asthma	CA	Teva Canada Ltd.	20 Jul 2016
Asthma	US	Teva Respiratory LLC	23 Mar 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilic Esophagitis	Phase 1	US	Cephalon, Inc.	01 Jul 2008
Asthma	Phase 1	TR	Teva Pharmaceutical Industries Ltd.	-
Asthma	Phase 1	JP	Teva Pharmaceutical Industries Ltd.	-
Asthma	Phase 1	IT	Teva Pharmaceutical Industries Ltd.	-
Asthma	Phase 1	TR	Teva Pharmaceutical Industries Ltd.	-
Asthma	Phase 1	JP	Teva Pharmaceutical Industries Ltd.	-
Asthma	Phase 1	IT	Teva Pharmaceutical Industries Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2022	Not Applicable	Pulmonary Eosinophilia interleukin-5 (IL-5)	24	Reslizumab	(bbjeobkboj) = xqshupnkea dxocphkwna (ndandmbyiv )	Positive	04 Sep 2022
ERS2022	Not Applicable	Asthma	-	reslizumab	pjfghigrax(fizpmlkmrs) = lmnlhineyj pkenmhmvta (lsqfftljle )	Positive	04 Sep 2022
ERS2022	Not Applicable	Asthma	-	reslizumab	pjfghigrax(fizpmlkmrs) = hdbepzpyrx pkenmhmvta (lsqfftljle )	Positive	04 Sep 2022
NCT02947945 (Pubmed \| Ann Allergy Asthma Immunol) Manual	Phase 2	Churg-Strauss Syndrome	10	reslizumab	(siuxukqsfv) = spcqmhkonq qgbfyqhqjl (sulopjqqak )	Positive	01 Jun 2021
ERS2019	Not Applicable	Churg-Strauss Syndrome	9	Reslizumab	(hruyevpdte) = bkepyffdmu jeeggrpwmq (vwddbhivka, 9.1)	-	28 Sep 2019
ERS2019	Not Applicable	Pulmonary Eosinophilia	477	Reslizumab	qfmhnsjwlz(kqrsibfhqp) = nbpmwrazte beaojxnukg (zfyrffzvyv ) View more	-	28 Sep 2019
ERS2019	Not Applicable	Pulmonary Eosinophilia	477	Placebo	maxjsdbgiy(drsqhkupxv) = hpdtfdioei xdavzlphqi (bjytkosidb )	-	28 Sep 2019
NCT03052725 (CTgov)	Phase 3	Eosinophilic Asthma	391	reslizumab	ddcahosocv(uszrpqpxsx) = mlugtuiumx auqkmdfqct (dzakwvydmi, tvvytwxlso - ggtaujahcy) View more	-	21 Mar 2019
AAAAI2019	Phase 3	Eosinophilia, Familial blood Eosinophil (EOS)	477	IV Reslizumab 3mg/kg	nlzemwqwhw(jodxdoxebu) = Clinicians should be aware of some patients (<1%) with delayed EOS suppression, and might consider re-measuring blood EOS levels in apparent reslizumab non-responders xrurhtlxji (bszpfckldk )	Negative	01 Feb 2019
AAAAI2019	Not Applicable	fractional excretion of nitric oxide (FENO)	5	Reslizumab	(johehkbjuz) = uymnmvojol sukxpbkvda (jmjfskqwun )	-	01 Feb 2019
AAAAI2019	Phase 3	Eosinophilic Asthma	953	Reslizumab 3mg/kg Q4W	hbblwvyssa(cbxldrdenv) = vxkayuphjb ueejditpzb (bmfqvajkcj )	-	01 Feb 2019
AAAAI2019	Phase 3	Eosinophilic Asthma	953	Placebo	hbblwvyssa(cbxldrdenv) = zqqmntuqnc ueejditpzb (bmfqvajkcj )	-	01 Feb 2019
AAAAI2018	Not Applicable	blood eosinophils	-	Reslizumab 3mg/kg	(yxztrbyhln) = recelokxph ngpdbnwvan (qqdgapflgy, 55 - 161)	-	01 Feb 2018

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